Comparing early proton pump inhibitor use to standard care for kidney injury in trauma patients
Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury (CEPU-AKI) in Hemorrhagic Shock Patients: A Prospective Randomized Controlled Trial
This study is testing if giving the heartburn medication pantoprazole early can help prevent kidney injury in trauma patients who are in shock.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06531642 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate whether the early initiation of the proton pump inhibitor pantoprazole can reduce the incidence of acute kidney injury (AKI) in trauma patients experiencing hemorrhagic shock. It is a single-center, randomized, controlled trial involving 100 adult patients who will be assigned to receive either early or routine administration of pantoprazole for two days following their injury. The study will assess kidney injury through urinary biomarkers and track the incidence and severity of AKI, as well as major adverse kidney events over a 30-day period. The findings could provide insights into optimizing treatment protocols for trauma patients at risk of kidney damage.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who meet the criteria for hemorrhagic shock due to traumatic acute bleeding.
Not a fit: Patients under 18 years of age, those on renal replacement therapy, or with a history of PPI sensitivity may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of acute kidney injury in trauma patients, leading to better outcomes and reduced mortality.
How similar studies have performed: While the specific approach of early PPI use in this context may be novel, similar studies have indicated potential benefits of early intervention in reducing organ damage in trauma patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient (≥18 years of age) * Patient meets hemorrhagic shock criteria: * Hypovolemic shock from traumatic acute bleeding * Systolic blood pressure ≤ 90 mmHg AND tachycardia (HR ≥ 108) at presentation to the ED; OR * Systolic blood pressure ≤ 70 mmHg at presentation to the ED. Exclusion Criteria: * Patients \<18 years of age * Patients known to be actively on renal replacement therapy * Cardiac arrest prior to ED arrival or who are deemed to have expected survival of less than 24 hours * History of PPI sensitivity or allergy * Patient who are already enrolled in other trials prior to ED arrival and these trials do not allow co-enrollment * Patient who presents with ongoing GI bleeding that will require higher dose of GI prophylaxis * Vulnerable populations such as pregnant women and prisoners
Where this trial is running
Houston, Texas
- Memorial Hermann Texas Medical Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Yafen Liang, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Yafen Liang, MD
- Email: yafen.liang@uth.tmc.edu
- Phone: 713-500-6226
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.